GCE HEALTHCARE Portable Oxygen Concentrator Models: RS-00600 & RS-00600C User Manual
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English User manual: Zen-O lite™ Portable Oxygen Concentrator (Models: RS-00600/RS-0600C) CONTENT 1. Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 EN 1.1. General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 1.2. Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8. Traveling with the Zen-O lite™ POC by Air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17 8.1. Passenger Pre-flight Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17 8.2. Boarding and In-flight Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 8.3. Transportation Security Administration (TSA) Requirements . . . . . . . . . . . . . . . . . . . . . .20 8.4.
1. FOREWORD Please refer to this manual for detailed instructions on warnings, cautions, specifications, and additional information. EN Important: Users should read this entire manual before operating the Zen-O lite™ Portable Oxygen Concentrator. Failure to do so could result in personal injury and/or death. If you have questions about the information in this user manual or about the safe operation of this system, contact your distributor. 1.1.
• ISO 7637-2:2011 Road Vehicles - Electrical disturbances from conduction and couplingPart 2: Electrical transient conduction along supply lines only. • Medical Device Directive 93/42/EEC. This equipment is classified as: • Class II • Class IIa according to the MDD 93/42/EEC • Type BF • IP22 with the carry bag EN 1.3. Typographical Conventions This user manual contains warnings, cautions, and notes to help call attention to the most important safety and operational aspects of the device.
3. SAFETY INSTRUCTIONS EN 3.1. Warnings Overview 1. The device must be used in the carry bag to provide protection from liquid intrusion from rain and/or spills. 2. There is a risk of fire associated with oxygen equipment and therapy. Do not use near sparks or open flames. 3. The settings of Zen-O lite™ Portable Oxygen Concentrator RS-00600/RS-0600C might not correspond with continuous flow oxygen. 4.
14. Do not use a device or any accessory that shows any sign of damage. 15. Do not use lubricants on this device or any of its accessories. 16. Use of this device at an altitude above 4,000 m (13,000 feet), or outside the temperature range of 5°C (41°F) to 40°C (104°F), or outside the humidity range of 5% to 93% may adversely affect the flowrate and percentage of oxygen and consequently the quality of therapy.
3.2. Cautions Overview 1. Keep away from heat sources (fireplaces, radiant heaters, etc.) that could cause the EN operating temperature at or near the device to exceed 40°C (104°F). 2. The display may be difficult to read under bright lighting conditions (sunlight, interior lights, etc.), move away from direct light for viewing the display. 3. Keep away from lint or other loose material that could block the air intake vents. 4.
16. Always follow the cannula manufacturer’s instructions for proper use. 17. Replace the cannula on a regular basis. Check with your home oxygen provider or clinician to determine how often the cannula should be replaced. 18. Check that this device operates on battery after disconnecting from the power source. 19. Only charge battery in this device or in an approved charger. (See approved accessories list.) 20. Remove battery if this device is not going to be used for more than seven days.
3.3. Important Information 1. EN If an extension cord is necessary, use a UL listed 15 amp or higher cord. Do not connect any other devices on the same extension cord. Do not use a multisocketed extension cord. 2. Inhale through the nose for the concentrator to work most effectively. Inhaling through the mouth may result in less effective oxygen therapy. 3. Your device is designed for everyday use, for optimum performance use your device for a minimum of 4 hours a day. 4.
5. PRODUCT DESCRIPTION 5.1. Schematic Description Breath detect LED Alarm mute indicator Red LED - warning Display screen Green LED - power ON Yellow LED - warning Pulse setting selection buttons Power button Battery indicator Alarm mute button Air intake Battery Exhaust vent Battery cover Nasal cannula port Power input Fig.
6. GENERAL INSTRUCTIONS BEFORE USE EN A variety of accessories can enhance the portability and use of the Zen-O lite™ Portable Oxygen Concentrator. In addition to the device, the package contains accessories to get started and a user manual. Contact your home oxygen provider for a complete list of available accessories. Always inspect the device and its accessories for any sign of damage before use. Important: While the box or packaging may exhibit some damage, e.g.
• European power cord (RS-00504) • Rechargeable battery (RS-00601) • United Kingdom cord (RS- 00506) • AC power supply – European cord • North America cord (RS-00503) (RS-00602) • External battery charger • AC power supply – United Kingdom - European (RS-00516) cord (RS-00603) • External battery charger • AC power supply – North America cord - North America (RS-00515) (RS-00604) • External battery charger • AC power supply without cord - United Kingdom (RS-00517) (RS-00612) • DC power supply (RS-00605) • Ca
IMPORTANT: Battery run time may vary based on breathing rate, age of battery, and environmental conditions. See displayed text on device for battery charge status. EN IMPORTANT: Ensure power status icon (see Fig. 7) indicates power is connected. If not, check that cord is plugged in completely (see Chapter 10 - Trouble shooting for more information) To maximise battery life and run time, avoid letting the battery deplete and use while connected to a power source whenever possible.
6.3. Nasal Cannula Only use a nasal cannula with the following specifications: • Length: 1.2m (4ft), 2.1m(7ft) or 7.6m(25ft) • High flow • Crush resistant • Large internal diameter bore • Suitable for up to 15 litres per minute (lpm) at a max. pressure of 3.6 psi • Meets substance compatibility of IEC/EN 60601-1 EN CAUTION: Only use approved accessories with this device. Refer to the approved accessories guide for a complete list of accessories and cannula approved for use with this device.
IMPORTANT: Improper cannula placement may result in the device being unable to detect all respiratory efforts of the patient. Ensure cannula is connected securely and it has been fully inserted. Cannula port 7.2. Turning On EN • To turn the device on, press the power button . • The concentrator will chirp and the green, yellow, and red LEDs will flash once, while the screen displays the device name.
IMPORTANT: If an air leak is suspected, leaks can be detected with a solution of soap and water applied to the cannula-concentrator connection point and looking for bubbles. The current setting and power source (external power or battery; battery icon also shows approximate level of charge remaining) are shown on the display screen as shown in Fig. 7. EN Zen-O lite™ operating on battery power. Fig. 7 Zen-O lite™ running on external power. 7.5.
7.7. Responding to Alarms EN CAUTION: If you are unable to hear or see alarms, do not have normal tactile sensitivity, or cannot communicate discomfort, consult your clinician before using this device. at any time will silence the buzzer. The length of the Pressing the alarm mute button mute period depends on the severity of the alarm (see Chapter 9 - Alarm Indicators). During this mute period, the mute LED will remain illuminated, indicating the alarm buzzer is muted.
8.1.2. Healthcare Provider Consultation The FAA does not require a passenger to consult with a healthcare provider prior to using a Zen-O lite™ POC on board an aircraft. However, you, together with your healthcare provider, may wish to discuss the following: • The effects of a pressurised cabin (cabin pressure altitude can reach 8,000 feet) on your oxygen needs.
EN 8.1.4. Documentation You are responsible for the operation of the Zen-O lite™ POC on board the aircraft. For this reason, the FAA recommends that passengers carry with them, at minimum, this User Manual and any other written information provided by your healthcare professional regarding the Zen-O lite™ POC and its use. 8.1.5.
8.2.2. Zen-O lite™ POC as Checked Baggage Your Zen-O lite™ POC may be carried on aircraft as a carry-on or as checked baggage. However, spare lithium batteries are prohibited from being carried in checked baggage on an aircraft. 8.2.3. Considerations Regarding Placement and Stowage of your Zen-O lite™ POC In order for a Zen-O lite™ POC to work efficiently, the air/intake vents must not be blocked during use.
EN 2. During movement on the surface, take-off, and landing, the nasal cannula tubing that is used to dispense oxygen from your properly stowed Zen-O lite™ POC may not stretch across the row in such a way as to restrict passenger access or become a tripping hazard in an evacuation. You must not restrict another passenger’s access during these phases of flight. In this case, a seating restriction may be required to comply with an FAA safety rule.
2. If a person has medical documentation regarding their medical condition or disability, they can present this information to the screener to help inform him or her of the person’s situation. This documentation is not required and will not exempt a person from the security screening process. 8.4. Placing your device in Airplane Mode If you have the RS-00600C model (this is stated on the back of your device), this means your device is connected to GCE's Clarity platform.
9. ALARM INDICATORS EN If the Zen-O lite™ Portable Oxygen Concentrator detects an alarm condition, it will indicate the alarm visually and audibly within 10 seconds. There are four levels of alarms: critical high priority, high priority, medium priority, and low priority. Each is indicated differently by the backlit display; yellow, and red LEDs; and buzzer, as indicated below. In each case, the alarm message and power status will override the current display.
button off to display the last highest priority alarm. Press the mute button on again to reset the eight-hour timer. 9.1. Alarms When the concentrator sounds an alarm, a corresponding message will be displayed on the screen. Take appropriate action as directed in the charts below. 9.1.1. Critical High Priority Alarms IMPORTANT: These alarms will disable the device immediately. Alarm message Description Battery needs charging. Battery is not an approved battery. Service required.
9.1.3. Medium Priority Alarms Alarm message Description No breath detected for 60 seconds EN Service required. Action Check the cannula connection. Be sure to breathe through nose, If alarm persists, contact your distributor. IMPORTANT: The message will be automatically cleared when breathing is detected. Contact your distributor. *Value: 51-70 9.1.4. Low Priority Alarms Alarm message Description Service required. Action Contact your distributor. *Value: 71-99 9.1.5.
Displayed percentage of battery charge if at least 10% and there is no external power connected. NN% displays the current battery charge level. Displayed when battery charge is greater than 10% but less than 100% and there is external power connected. Battery charge is less than 10% and there is external power connected. The patient’s average breath rate when the device is delivering the maximum amount of oxygen and the bolus is reduced. If no breaths are detected, the most recent breath rate is shown.
Any alarm sound or either • See Chapter 9 Alarm Indicators. See Chapter 9 - Alarm Indicators. • Power is not connected. • Check connections to ensure: • Round receptacles are secure in unit. • Power cord is connected to AC/DC supply or automotive DC adapter is connected, if applicable. • Power cord is connected to wall outlet, if applicable. • Wall outlet has power. • Ensure battery is fully seated and battery cover is secure. • If problem persists, contact your distributor.
CAUTION: Do not use cleaning agents other than those specified in this manual. Allow the cleaning solution to dry from the cleaned surface before use. CAUTION: Always disconnect power and turn off this device before cleaning. Clean the exterior with a soft cloth slightly dampened with soapy water or with anti-bacterial wipes (Isopropyl alcohol 70% solution). For disinfecting, use a MadaCide-FDW-Plus wipe or equivalent and follow the manufacturer's instructions. (Manufacturer - Mada Medical Products Inc., www.
EN 3. Remove the battery from the device. 4. Press the four release buttons located at the top of the device to remove the top cover of the device as shown in Fig. 9. 5. Use the tool included with the replacement sieve modules package to rotate the sieve counter clockwise 3 - 4 turns until it can be removed by pulling up towards the top of the device. 6. Repeat for the second sieve module. 7.
e. Press the battery button to exit the diagnostic mode. f. The device is now ready to be used. Important: Contact your home oxygen provider or distributor if the device does not pass after multiple attempts. 12.3. Disposal • Contact your distributor regarding disposal of the device. • Dispose of battery according to local regulations or contact your distributor. 13.
15. TECHNICAL DESCRIPTION Size: Unit weight: Power requirements: EN Purity: Setting: Inspiratory trigger sensitivity: Setting indicator: Maximum oxygen discharge pressure: Humidity range: Disconnect Device: Operating altitude: Sound level: Type of protection (electrical): Degree of protection (electrical): 249 mm (W), 97 mm (D), 235 mm (H) 9.8" (W), 3.8" (D), 9.25" (H) 2.5 kg (5.5 lbs) (without carry bag) AC adaptor: 100-240V AC (+/- 10%), 50-60 Hz in, 24V DC, 5.0A out. DC adaptor: 11.
Degree of protection (water): Degree of safety (flammable anaesthetic mixture): Operating temperature: Storage temperature: Alarm sound pressure range: Alarm system delays: Oxygen concentrator status indicator: IP22 in carry bag (protection against small objects and tilted dripping water) IP20 out of carry bag (protection against small objects and no protection against water entering the concentrator) Not suitable for use in the presence of a flammable anaesthetic mixture Continuous operation at temperatur
Eco Mode bolus size (ml/breath) versus setting and breath rate Breath per minute EN 15 20 25 30 35 40 1 14 10.5 8.4 7 6 5.25 2 26.4 19.8 15.8 13.2 11.3 9.9 Setting 3 42 31.5 25.2 21 18 15.75 4 56 42 33.6 28 24 21 5 70 52.5 42 35 30 26.25 All values +/- 15% over all operating conditions 15.1. Electromagnetic Compatibility (EMC) Information Medical electrical equipment requires special cautions regarding electromagnetic compatibility (EMC).
15.1.2. Guidance and Manufacturer’s Declaration: Electromagnetic Immunity Zen-O lite™ is intended for use in the electromagnetic environment specified below. The customer or the user of the concentrator should assure that it is used in such an environment.
EN Power 30 A/m 30 A/m frequency (50/60 Hz) magnetic field IEC 61000-4-8 Immunity test IEC 60601 test Compliance level level Conducted RF 3 Vrms 150 kHz 3 Vrms (6Vrms ISM IEC 61000-4-6 to 80 Mhz ; 6Vrms ISM Bands) Bands Radiated RF 10 V/m 80 Mhz 10 V/m IEC 61000-4-3 to 2.5 Ghz IMPORTANT: At 80 MHz and 800 MHz, the higher frequency range applies. IMPORTANT: These guidelines may not apply in all situations.
15.1.3. Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Zen-O lite™ Portable Oxygen Concentrator The Zen-O lite™ Portable Oxygen Concentrator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
• Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. 15.3. EU RED ARTICLE 10(10) RESTRICTIONS ON USE FOR MODEL RS-00600C: EN Based on the information available from the European Communication Office (ECO) Frequency Information System (EFIS), Zen-O lite™ (model RS-00600C) complies with stipulated radio frequency radiation limits.
The SAR limit is 1.6 watts for kilogram in countries that set the limit averaged over 1 gram of tissue and 2.0 watts per kilogram in countries that set the limit averaged over 10 grams of tissue. The highest SAR values measured in accordance with ICNIRP guidelines for this device with an 8mm separation as provided by the carry bag are: Body SAR at 1g: 1.50 W/Kg Body SAR at 10g: 1.
No Smoking EN Dispose of used battery properly No smoking Separate collection for electrical and electronic equipment Complies with applicable EU Directives including Medical Device Directive 40/316 Class II symbol Suitable for homecare use
EN GCE Ltd 100 Empress Park, Penny Lane, Haydock, St Helens WA11 9DB 0088 United Kingdom 41/316 Manufactured for: GCE Ltd Jesus Siqueiros #652, 83170 Hermosillo, Mexico
